Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03682549 |
| Other study ID # |
A1PhD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2019 |
| Est. completion date |
March 14, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Hepatitis C virus (HCV) infection is very common in Egypt and the middle east. The disease
affects multiple body organs and may proceed to hepatocellular carcinoma. The viral disease
causes changes in the microbial symbiosis in the human body. Thus, the analysis of the
microbiome may provide a means of diagnosis for HCV infection.
Thus, this study will be held to detect if the microbiome of patients having HCV differ from
that of normal individuals.
Description:
Human oral cavity is a great habitat for more than 600 species of bacteria, known as oral
microbiota, living in equilibrium. Oral microbiota plays an important role in maintaining
oral health; however when the balance in oral bacterial population is disturbed- known as
dysbiosis- oral and systemic diseases may arise.
Some systemic diseases were proven to be associated with oral dysbiosis. Among these diseases
are diabetes mellitus, cardiovascular diseases, breast cancer, pancreatic cancer, autoimmune
liver diseases, hepatic encephalopathy and hepatitis B infection.
Hepatitis C virus (HCV) is considered an epidemic disease in Egypt; affecting about 10% of
Egyptians ranging between 15 and 59 years of age. HCV infection damages the liver
progressively causing liver cirrhosis, hepatic encephalopathy and may proceed to
hepatocellular carcinoma.
Due to being a serious disease, together with the promising results of the newly discovered
directly acting antiviral agents in treatment of chronic HCV, medicine has been concerned
with finding efficient methods for its early diagnosis; in order to ensure early effective
treatment and prevent serious complications.
Evidence suggests that a link exists between dysbiotic oral microenvironment and liver
disease through oral-liver-gut axis. Attempts have been made to investigate the complex oral
microbiota. With the advent of whole-genome sequencing technology, the genome of microbes
have been possible to be sequenced in what is known as microbiome. Analyzing the genome of
complex environment containing multiple individual microbes is called metagenomics.
Oral microbiome depends on sequencing of the 16S rRNA to provide a map of all oral microbiota
available in the oral cavity. The technology of oral microbiome sequencing advanced from
Sanger sequencing, that had shallow sequencing effort, to high throughput sequencing combined
with bioinformatic tools, that allowed for comprehensive study of the complex microbiome.
Dysbiosis has been used for diagnosis of liver diseases through stool analysis. Only one
study used oral dysbiosis to diagnose hepatic encephalopathy and another one used it in
testing hepatitis B infection. However, oral dysbiosis has not been used to diagnose HCV
infection before.
Understanding the oral microbiome at state of health and its change at state of disease can
help predict the early stages of disease and treat it before further damage and disease
progression occur. It can also help treat each patient according to the specific microbiome
detected through personalized medicine. Furthermore, targeted treatment to each patient's
specific microbiome can be introduced using specific prebiotics and probiotics to maintain
the bacterial symbiosis and so assist the immune system in its continuous antiviral battle.
